Dry powder dispersing apparatus and methods for their use

ABSTRACT

The invention provides various apparatus and methods for aerosolizing a powdered medicament. In one exemplary embodiment, an apparatus includes a pressurization cylinder, and a piston which is slidable within the cylinder to pressurize a gas. A handle is coupled to the piston and is movable between an extended position and a home position to pressurize the gas. An aerosolizing mechanism is included and is configured to aerosolize a powdered medicament that is held within a receptacle with pressurized gas from the cylinder. A carriage assembly is included to receive the receptacle and to couple the receptacle to the aerosolizing mechanism. A first and a second interlock are operably engageable with the carriage assembly to prevent coupling of the receptacle with the aerosolization mechanism. The first interlock is released to allow movement of the carriage upon movement of the handle to the extended position. The second interlock remains engaged if the receptacle is only partially inserted into the carriage assembly.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.11/076,418, which is a continuation of U.S. patent application Ser. No.10/327,633, filed Dec. 19, 2002, now U.S. Pat. No. 6,901,929, which is acontinuation of U.S. patent application Ser. No. 09/873,946, filed Jun.4, 2001, now U.S. Pat. No. 6,546,929, which is a continuation of U.S.patent application Ser. No. 09/312,434, filed May 14, 1999, now U.S.Pat. No. 6,257,233, and claims the benefit of U.S. Provisional PatentApplication Ser. No. 60/087,929, filed Jun. 4, 1998, the completedisclosure of which is herein incorporated by reference.

BACKGROUND OF THE INVENTION

The invention relates generally to the field of pulmonary drug delivery.More specifically, the invention relates to dry powder dispersiondevices and methods for dispersing dry powder medicaments for inhalationby a patient.

Pulmonary drug delivery is becoming a promising way to deliver drugs toa patient. Pulmonary drug delivery relies on inhalation of a drugdispersion or an aerosol by the patient so that the active drug withinthe dispersion can reach the distal (alveolar) regions of the lung. Ithas been found that certain drugs are readily absorbed through thealveolar regions directly into blood circulation. For example, pulmonarydelivery is particularly promising for the delivery of proteins andpolypeptides which are difficult to deliver by other routes ofadministration. Such pulmonary delivery is effective both for systemicdelivery and for localized delivery to treat diseases of the lungs.

A variety of approaches have been proposed to achieve pulmonary drugdelivery. Such approaches include the use of liquid nebulizers, metereddose inhalers (MDI's) and dry powder dispersion devices. Of theseapproaches, dry powder dispersion devices are of particular interest.Exemplary embodiments of such dry powder dispersion devices aredescribed in U.S. Pat. No. 5,740,794 and Ser. No. 08/309,691, filed Sep.21, 1994, the complete disclosures of which are herein incorporated byreference. These patents describe hand-held powder dispersion deviceswhich extract powder from a receptacle and aerosolize the powder so thatthe aerosolized powder may be inhaled by a patient. Such dry powderdispersion devices have proven to be tremendously successful inadequately aerosolizing dry powders for subsequent inhalation.

Even so, it would be desirable to provide various enhancements toincrease the marketability, ease of use, functionality, and otherfeatures of such dry powder dispersion devices. Hence, it is an objectof the invention to provide improved dry powder dispersion devices andmethods for their use.

SUMMARY OF THE INVENTION

The invention provides exemplary systems, apparatus and methods foraerosolizing a powdered medicament. One exemplary apparatus of theinvention comprises a pressurization cylinder and a piston that isslidable within the cylinder to pressurize a gas within the cylinder. Ahandle is coupled to the cylinder and is movable between an extendedposition and a home or retracted position to pressurize the gas withinthe cylinder. An aerosolizing mechanism is further provided toaerosolize a powdered medicament that is held within a receptacle usingpressurized gas from the cylinder. A carriage assembly is provided toreceive the receptacle and to couple the receptacle to the aerosolizingmechanism so that the powder may be extracted from the receptacle andaerosolized. The apparatus further includes a first and a secondinterlock which may be operated to engage the carriage assembly, therebypreventing coupling of the receptacle with the aerosolizing mechanism.The first interlock is released to allow movement of the carriage whenthe handle is moved to the fully extended position. The second interlockbecomes engaged with the carriage when the receptacle is only partiallyinserted into the carriage assembly.

With such a configuration, the apparatus is operated to aerosolize thepowdered medicament by inserting the receptacle into the carriageassembly to a fully loaded position to ensure that the second interlockis not engaged with the carriage assembly. The handle is then extendedto a fully extended position and retracted back to the home position toproduce a charge of pressurized gas and to release the first interlockfrom the carriage assembly. A fire button on the apparatus is thenoperated to move the carriage assembly toward the aerosolizing mechanismuntil the receptacle is coupled with the aerosolizing mechanism. Uponcoupling of the aerosolizing mechanism, the charge of pressurized gas isreleased to aerosolize the powdered medicament that is held within thereceptacle.

Such a configuration is advantageous in that the aerosolizing apparatusmay not be operated if the receptacle is not fully inserted and thehandle is not fully extended. In this way, controls are provided toensure correct operation of the aerosolization apparatus.

In one particularly preferable aspect, the receptacle has a front end, aback end, and a cavity which holds the medicament. The front endincludes at least one notch, and the carriage assembly includes a key sothat the receptacle may not be fully inserted into the carriage assemblyif the notch does not mate with the key. In this way, the carriageassembly may not be operated to couple the receptacle with theaerosolizing, mechanism if the notch does not mate with the key, therebypreventing full insertion of the receptacle into the carriage assembly.

In one particular aspect, the aerosolization apparatus further includesa sensor arm having a roller. The roller rolls over the cavity duringinsertion of the receptacle into the carriage assembly to move thesensor arm against the second interlock, thereby causing a latch on thesecond interlock to engage the carriage assembly until the roller rollsover the entire cavity. In this way, the latch will remain engaged withthe carriage assembly to prevent its movement as long as the roller isin apposition to the cavity. Once fully inserted, the latch is releasedto allow operation of the carriage assembly. In still a further aspect,the sensor arm defines a well which receives the cavity when thereceptacle is fully inserted. The well aligns the cavity with theaerosolizing mechanism to facilitate coupling of the receptacle to theaerosolizing mechanism.

In one particular aspect, the apparatus further includes a catch whichengages the carriage assembly when the carriage assembly is moved tocouple the receptacle to the aerosolizing mechanism. A release button isprovided to release the carriage assembly from the catch. In this way,the carriage assembly will not accidentally be lowered to decouple thereceptacle from the aerosolizing mechanism until the powdered medicamenthas been aerosolized. In another aspect, a valve is disposed in anairway between the cylinder and the aerosolizing mechanism. The valvehas an open position and a closed position, and is generally in theclosed (but unlocked) position during extension of the handle to theextended position. Such a configuration is advantageous in that the airemployed to fill the cylinder is not drawn through the airway, therebyproviding a cleaner supply of air to fill the cylinder.

In one particular embodiment, an aerosolizing apparatus is providedwhich comprises a housing, a pressurization cylinder, and a piston thatis slidable within the cylinder to pressurize a gas within the cylinder.The piston is pivotally attached to the housing, and a handle isoperably attached to both the housing and cylinder. The handle isoperated to move the cylinder relative to the piston to pressurize a gaswithin the cylinder. An aerosolization mechanism is provided to receivegas from the cylinder to aerosolize a powdered medicament. Constructionof the apparatus in this manner is advantageous in that the piston maypivot relative to the housing as the handle is operated. In this way,the piston remains generally aligned with the cylinder during operationof the handle, thereby facilitating operation of the handle and reducingwear between the components.

In one particular aspect, a linkage is disposed between the handle andthe cylinder. The linkage is pivotally attached to the housing and thecylinder to further facilitate operation of the handle. In anotheraspect, the housing includes a top end and a bottom end, and theaerosolizing mechanism is disposed near the top end. Further, the pistonis pivotally attached to the housing at the bottom end. Such aconfiguration is advantageous when a one-way check valve is disposed inthe piston because the check valve will be disposed near the bottom endof the housing to reduce the chances of having any powder which may fallthrough the housing from accumulating on the check valve.

In a further embodiment, the invention provides an aerosolizing devicewhich comprises a housing and a capture chamber which extends from thehousing. An aerosolizing mechanism is disposed in the housing tointroduce a powdered medicament into the capture chamber. Theaerosolizing mechanism is provided with air channels which allow air toenter into the capture chamber when a patient inhales to extract thepowdered medicament from the capture chamber. The aerosolizing mechanismfurther includes a structure to distribute air entering into the capturechamber through the air channels such that the powdered medicament isremoved from the capture chamber as a bolus that is substantiallyunmixed with the entering air.

Such a device is operated by dispersing the powdered medicament into thecapture chamber and then inhaling from the capture chamber to extractthe powdered medicament. Air is allowed to enter into the capturechamber through the air channels in a manner such that substantiallynone of the incoming air mixes with the powdered medicament to allow themedicament to be removed as a bolus. Hence, by introducing the air inthis manner, the air serves as a piston to uniformly lift theaerosolized powder up through the capture chamber where it is inhaled bythe patient.

In one particular aspect, the capture chamber has a geometric center andthe aerosolizing mechanism is offset from the center because of theinclusion of other component parts within the housing. The structure isfashioned to distribute more air to regions of the capture chamber whichare more remote from the geometric center. In this way, the remotestregions of the capture chamber will receive more air so thatsubstantially no mixing of the powdered medicament occurs as air isdrawn into the capture chamber during inhalation by the patient. Inanother aspect, the structure comprises a curved flange member andserves to channel some of the air radially outward as it enters into thecapture chamber.

In one particularly preferable aspect, the aerosolizing mechanismincludes a cylindrical passage or channel through which the powderedmedicament passes to reach the capture chamber. The top end of thehousing is generally perpendicular to a distal end of the passage. Inthis way, as the powdered medicament enters into the capture chamber, itwill tend to disperse evenly throughout the capture chamber. In yetanother aspect, a flexible seal is coupled to the housing to provide aseal with the capture chamber. The flexible nature of the seal isadvantageous in that the capture chamber may easily be slid over thehousing without causing excessive wear to the seal.

In one particular embodiment, the invention provides a device foraerosolizing a powdered medicament which comprises a housing having atleast one piercing element for piercing a hole in a receptacle thatcontains a powdered medicament. A core is insertable into the housingand has an extraction lumen or tube and at least one air channel. Theair channel is aligned with the piercing element when the core isinserted into the housing to allow air to flow into the receptaclethrough the air channel. A source of pressurized gas is further providedto extract the powdered medicament through the extraction lumen when theextraction lumen is inserted into the receptacle. Use of the housing andcore is advantageous in that the core may be manufactured with arelatively small cost and may be made disposable, while the housingwhich includes the piercing element may be re-used.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exploded front perspective view of an exemplary apparatusfor aerosolizing a powdered medicament according to the invention.

FIG. 2 is a rear perspective view of the apparatus of FIG. 1.

FIG. 2A is a cross-sectional side view of a seal for engaging a neckedregion of the capture chamber of the apparatus of FIG. 1 according tothe invention.

FIG. 3 is a perspective view of an exemplary core of an aerosolizationmechanism according to the invention.

FIG. 4 is a housing of an exemplary aerosolization mechanism which isadapted to receive the core of FIG. 3 according to the invention.

FIGS. 3A and 3B are cross-sectional side views of the core of FIG. 3taken along lines A-A and B-B, respectively.

FIGS. 4A and 4B are cross-sectional side views of the housing of FIG. 4taken along lines A-A and B-B, respectively.

FIG. 5 illustrates the core of FIG. 3A inserted into the housing of FIG.4A to form an aerosolization mechanism, with the aerosolizationmechanism being coupled to a receptacle and showing the manner of powderextraction from the receptacle according to the invention.

FIG. 6 illustrates the aerosolization mechanism of FIG. 5 taken alonglines 6-6.

FIG. 7 illustrates the aerosolization mechanism of FIG. 5 showing themanner of air distribution as a patient inhales to draw air through theaerosolization mechanism according to the invention.

FIG. 8 illustrates the aerosolization mechanism of FIG. 7 taken alonglines 8-8.

FIG. 9 is a schematic diagram of an air capture chamber showing thepattern of air flow that is produced upon inhalation by a patientaccording to the invention.

FIG. 9A is a schematic diagram of a capture chamber illustrating removalof an aerosolized medicament upon inhalation by a patient according tothe invention.

FIG. 10 is a cross-sectional side view of a base unit of the apparatusof FIG. 1 taken along lines 10-10 (when the aerosolization mechanism anda receptacle are inserted into the base unit).

FIGS. 10A-10P illustrate cross-sectional side views of the base of FIG.10 taken along lines A-A through P-P, respectively (with the base unitbeing in various states of operation).

FIG. 11 is a cross-sectional side view of the aerosolization apparatusof FIG. 1 showing the handle extended to pressurize a gas within acylinder according to the invention.

FIG. 11A illustrates a magnified view of the base of the aerosolizationapparatus of FIG. 11.

FIG. 11B is a cross-sectional side view of the apparatus of FIG. 11taken along lines B-B.

FIG. 11C is a cross-sectional top view of the aerosolization apparatusof FIG. 11 taken along the lines C-C.

FIG. 12 is a cross-sectional side view of the aerosolization apparatusof FIG. 1 showing the handle in a home or retracted position after thepressurized gas has been produced within the cylinder according to theinvention.

FIG. 12A illustrates a magnified view of the base of the aerosolizationapparatus of FIG. 11.

FIG. 12B is a cross-sectional side view of the apparatus of FIG. 12taken along lines B-B.

FIG. 12C is a cross-sectional top view of the aerosolization apparatusof FIG. 12 taken along the lines C-C.

FIG. 13 illustrates a top view of one embodiment of a receptacle havinga keyed notch to regulate insertion of the receptacle into anaerosolization apparatus according to the invention.

FIG. 14 illustrates another alternative embodiment of a receptaclehaving a pair of keyed notches according to the invention.

DESCRIPTION OF THE SPECIFIC EMBODIMENTS

Referring now to FIGS. 1 and 2, an exemplary embodiment of an apparatus10 for aerosolizing a powdered medicament will be described. Apparatus10 comprises a base unit 12 and a capture chamber 14 which is removablyattachable to base unit 12. Capture chamber 14 is configured to slideover base unit 12 to reduce the overall size of apparatus 10 duringstorage and to protect the components within base unit 12. Shownexploded from base unit 12 is an aerosolization mechanism 16 whichcomprises a core 18 and a housing 20. Base unit 12 includes an opening21 to receive aerosolization mechanism 16. Base unit 12 is configured toreceive a receptacle 22 which holds a powdered medicament. Apparatus 10is operated to couple aerosolization mechanism 16 with receptacle 22,and then to extract the powdered medicament from receptacle 22. Theextracted powder is then deagglomerated and dispersed and delivered intocapture chamber 14 where it will be available for inhalation by apatient.

Capture chamber 14 includes a mouthpiece 24 that is rotatable between anopen position and a closed position. During aerosolization, mouthpiece24 is in the closed position as shown in FIGS. 1 and 2. When the patientis ready to inhale the aerosolized medicament, mouthpiece 24 is rotated180 degrees to the open position where the patient may place his mouthover the mouthpiece and inhale the powdered medicament from capturechamber 14.

As previously mentioned, capture chamber 14 is slidable over base unit12 to reduce the size of apparatus 10 during storage and to protect thecomponents of base unit 12. Base unit 12 includes a seal 26 whichextends radially outward from base unit 12 and engages the walls ofcapture chamber 14 so that a seal is provided between base unit 12 andcapture chamber 14. As best shown in FIG. 2A, capture chamber 14includes a necked region 28 which comes into contact with seal 26 ascapture chamber 14 is moved to a fully extended position. Seal 26 ispreferably constructed of a rubber using a two-shot molding process toattach seal 26 to base unit 12. Use of necked region 28 is particularlyadvantageous in that seal 26 disengages from capture chamber 14 ascapture chamber 14 is slid over base unit 12 to a closed or storageposition. In this way, wear of seal 26 is significantly reduced.

Referring back to FIGS. 1 and 2, necked region 28 further includes apair of apertures 30 into which a pair of latches 32 on base unit 12 arereceived when capture chamber 14 is moved to the extended position. Uponreaching the extended position, the latches, which are spring-biased,slide into apertures 30 to prevent capture chamber 14 from being pulledfrom base unit 12. Further, engagement of latches 32 with apertures 30maintain the capture chamber 14 in the extended position so that it willnot accidentally slide back over base unit 12. To disengage latches 32from apertures 30, a chamber release button 34 is depressed. Upondepression of chamber release button 34, latches 32 are moved back intobase unit 12 where capture chamber 14 may be removed from base unit 12or slid back over base unit 12 to the storage position.

Conveniently, base unit 12 includes a pull ring 36 which may be graspedwith a finger of one hand while capture chamber 14 is grasped with theother hand to facilitate movement of capture chamber 14 from the storageposition to the extended position. Pull ring 36 is attached to base unit12 by a spring-loaded hinge mechanism so that pull ring 36 will returnto a flush position with base unit 12 when not in use.

Apparatus 10 is operated by inserting receptacle 22 into a carriageassembly 38 of base unit 12. Optionally, apparatus 10 may be operatedwithout inserting a receptacle if it is desire to do a “dry fire.” Asdescribed in greater detail hereinafter, apparatus 10 cannot be operatedunless receptacle 22 is fully inserted into carriage assembly 38. Hence,such a configuration provides a way to prevent coupling ofaerosolization mechanism 16 to receptacle 22 unless receptacle 22 isproperly inserted.

To aerosolize the medicament, a pump handle 40 is extended away frombase unit 12. As described in greater detail hereinafter, when pumphandle 40 is extended to a fully extended position and then pushedinwardly back to the home or retracted position (as illustrated in FIGS.1 and 2), a compressed gas is provided within a cylinder in base unit12. The compressed gas is then released where it will flow throughaerosolization mechanism 16 when a fire button 42 (see FIG. 2) ispressed. When fire button 42 is pressed, carriage assembly 38 isoperated to move receptacle 22 into engagement with aerosolizationmechanism 16 where holes 44 are pierced into receptacle 22. Just afterholes 44 are pierced with aerosolization mechanism 16, the pressurizedgas within base unit 12 is released to extract the powdered medicamentfrom receptacle 22, deagglomerate and disperse the powdered medicament,and deliver the powdered medicament in aerosolized form into capturechamber 14 in a manner similar to that described in U.S. Pat. No.5,740,794, previously incorporated by reference.

As described in greater detail hereinafter, one feature of apparatus 10is that, in addition to preventing coupling of receptacle 22 toaerosolization mechanism 16 if receptacle 22 is not fully inserted intocarriage assembly 38, fire button 42 may not be operated if pump handle40 has not been extended to the fully extended position. In this way,operation of apparatus 10 is prevented unless the user has fullyextended handle 40 so that a proper amount of pressurized gas may beprovided (upon retraction of handle 40 to the retracted position) toallow aerosolization mechanism 16 to operate properly.

Hence, apparatus 10 is provided with two compliance features to helpensure the proper production of the aerosolized medicament withincapture chamber 14. First, receptacle 22 must be fully inserted intocarriage assembly 38. Second, handle 40 must be fully extended to theextended position. If both of these conditions are not satisfied, firebutton 42 cannot be pressed to couple receptacle 22 to aerosolizationmechanism 16 and to release the pressurized gas to extract the powderfrom receptacle 22.

When fire button 42 is pressed, carriage assembly 38 is lifted to couplereceptacle 22 with aerosolization mechanism 16 which aerosolizes thepowder within receptacle 22. Following operation of fire button 42 toaerosolize the medicament, receptacle 22 remains coupled withaerosolization mechanism 16 and therefore cannot removed from carriageassembly 38. To uncouple receptacle 22 from aerosolization mechanism 16,a release button 46 is pressed to lower carriage assembly 38. Receptacle22 may then be removed from carriage assembly 38 where it will includeholes 44.

One particular advantage of releasing the pressurized gas immediatelyafter holes 44 are pierced in receptacle 22 is that the user isprevented from coupling receptacle 22 with aerosolization mechanism 16and then delaying the release of the pressurized gas. In this way, thepowdered medicament within receptacle 22 will not experience prolongedexposure to the environment which may degrade the medicament.

Referring now to FIGS. 3-3B and 4-4B, construction of aerosolizationmechanism 16 will be described in greater detail, with core 18 beingillustrated in FIGS. 3-3B and housing 20 being illustrated in FIGS.4-4B. Core 18 includes an extraction tube 48 having a pointed tip 50which is adapted to pierce a hole within a receptacle, such as forexample the center hole 44 in receptacle 22 (see FIG. 1). Pointed tip 50includes a pair of apertures 52 which allow the powdered medicamentwithin the receptacle to be drawn into extraction tube 48. Coupled toextraction tube 48 is a nozzle 54 which in turn is in communication witha high-pressure gas inlet 56 (see FIG. 3B). Extending from nozzle 54 isa deagglomeration channel 58 which terminates in an exit opening 60.Core 18 further includes a plurality of air channels 62 which serve bothto allow air into a pierced receptacle during aerosolization and toprovide an air passageway into the capture chamber when a patientinhales the aerosolized medicament as described in greater detailhereinafter. When coupled with housing 20, core 18 aerosolizes apowdered medicament within a receptacle in a manner similar to thatdescribed in U.S. Pat. No. 5,740,794 and Ser. No. 08/309,691, filed Sep.21, 1994, previously incorporated by reference. Operation ofaerosolization mechanism 16 to aerosolize a powdered medicament willalso be described in greater detail hereinafter with reference to FIGS.5-8.

Disposed over air channels 62 by a set of ribs 64 is a curved flangemember 66. Curved flange member 66 serves to distribute chase air intothe aerosolization chamber with an axial and a radial component tofacilitate removal of the aerosolized medicament as described in greaterdetail hereinafter. Conveniently, ribs 64 divide air channels 62 intofour quadrants. As described in greater detail hereinafter, the size ofthe four quadrants may be varied to vary the volume of air that passesthrough each of the quadrants.

Core 18 further includes a flat surface 68 which is aligned with a flatsurface 70 of housing 20 to facilitate proper alignment of core 18 wheninserted into housing 20. When core 18 is inserted into housing 20, anedge 72 of core 18 rests upon a top end 74 of housing 20. Core 18 alsoincludes a lip 76 which rests upon a top end of base unit 12 whenaerosolization mechanism 16 is inserted into opening 21 of base unit 12.Conveniently, housing 20 includes a key 78 to assist in properorientation of aerosolization mechanism 16 into base unit 12.

Referring now to FIGS. 4-4B, construction of housing 20 will bedescribed in greater detail. Housing 20 includes a pair of side punches80 which are configured to punch a pair of holes into a receptacle, suchas the outer holes in receptacle 22 of FIG. 1. Side punches 80 areangled so that they will peel back the receptacle as they enter. A pairof openings 82 are provided in housing 20 and are in fluid communicationwith air channels 62 when core 18 is inserted into housing 20. In thisway, air may travel through air channels 62, through openings 82 andinto the receptacle to assist in the extraction of the powderedmedicament. Housing 20 further includes a hole 84 (see FIG. 4B) throughwhich pointed tip 50 of core 18 is received when core 18 is coupled tohousing 20. A stop 86 is provided on housing 20 and serves to stoppenetration of side punches 80 and pointed tip 50 when couplingaerosolization mechanism 16 to a receptacle. A seal 87 is provided toform a seal between aerosolization mechanism 16 and receptacle 22.

As best shown in FIGS. 4A and 4B, a port 88 is disposed in housing 20and is aligned with high-pressure gas inlet 56 when core 18 is insertedinto housing 20. As best shown in FIG. 4B, housing 20 is constructed ofa resilient material in the region around port 88 and stop 86 to providean overmold seal 90. Seal 90 provides a seal between port 88 and a valvethrough which the high-pressure gas is provided to extract anddeagglomerate the powder from the receptacle, and to provide a sealbetween stop 86 and the receptacle. Overmold seal 90 may be constructedusing a two-shot molding process as is known in the art. Further, theangled nature of seal 90 in the vicinity of port 88 assists in properlyaligning port 88 with the air flow tube which delivers the pressurizedgas through nozzle 54. As best shown in FIGS. 4 and 4B, housing 20further includes an inlet check valve 92 which allows air into housing20 when a patient inhales from the capture chamber to extract theaerosolized medicament from the capture chamber. Check valve 92 isconstructed as a mushroom valve which opens after experiencing athreshold pressure. Use of such a valve is advantageous in that apressure drop is created when a patient begins to inhale so that agenerally uniform pressure may be produced within a plenum 94 (see FIG.6). As described in greater detail hereinafter, by providing a generallyuniform pressure within plenum 94, the management of air flow into thecapture chamber may be better controlled.

One particular advantage of constructing core 18 so that it is removablefrom housing 20 is that core 18 may be periodically removed and replacedwith a new core. In this way, the life of the aerosolization apparatusmay be greatly increased. Further, by including the more expensivecomponents on housing 20, the cost of replacing the core can be greatlyreduced. Although shown as being constructed from two components, itwill be appreciated that aerosolization mechanism 16 may also beconstructed as an integral system.

Referring now to FIGS. 5-8, operation of aerosolization mechanism 16 toextract a powdered medicament from receptacle 22, to deagglomerate thepowdered medicament, and to deliver the powdered medicament inaerosolized form into a capture chamber will be described. Whenreceptacle 22 is coupled to aerosolization mechanism 16, seal 87 isplaced adjacent to a top surface 96 of receptacle 22 to form a sealbetween aerosolization mechanism 16 and top surface 96. Further, stop 86engages carriage assembly 38 (see FIG. 10N) to prevent further upwardtravel of carriage assembly 38. Pointed tip 50 and side punches 80penetrate top surface 96 and are disposed within a cavity or pocket 98which holds the powdered medicament. To extract the powdered medicament,a high-pressurized gas is supplied through port 88 and high-pressure gasinlet 56 as shown by the arrows. The high-pressurized gas passes throughnozzle 54 causing air to entrain through air channels 62, through pocket98 and through extraction tube 48 as indicated by the arrows. Theentrained air is included in a closed air circuit which includes air inthe capture chamber, in the aerosolization mechanism, and in thereceptacle. Such a process is essentially identical to that described inU.S. Pat. No. 5,740,794, previously incorporated by reference.

The powdered medicament within extraction tube 48 then entersdeagglomeration channel 58 which serves to deagglomerate the powder sothat it will be suitable for inhalation. Deagglomeration channel 58preferably has a constant diameter with a length that is approximatelyone times the diameter to about ten times the diameter, more preferablythree times the diameter to about seven times the diameter, and mostpreferably at about five times the diameter. As shown in the drawings,deagglomeration channel 58 terminates abruptly at exit opening 60. Inthis way, a “dump diffuser” is provided so that the gas flow out ofdeagglomeration channel 58 will tend to further break apart the powderedmedicament and not slow down. In this manner, the dispersement of theaerosolized medicament into the capture chamber is improved.

Following dispersement of the powdered medicament into the capturechamber, the patient inhales to extract the powdered medicament from thecapture chamber, causing chase air to flow through aerosolizationmechanism 16 as illustrated in FIGS. 7 and 8. When the patient inhales,replacement (or chase) air needs to be introduced into the capturechamber to allow the aerosolized medicament to be removed. Such chaseair passes through aerosolization mechanism 16 after entering intoplenum 94 through inlet check valve 92. An opening 100 (see FIG. 8) isprovided in housing 20 to allow the chase air to open inlet valve 92 andpass through air channels 62 as indicated by the arrows.

Aerosolization mechanism 16 is designed so that the chase air enteringthe capture chamber is managed to minimize the amount of mixing of theaerosolized medicament with the entering chase air. In this way, thepowdered medicament may be extracted from the chamber in a bolusfollowed by the chase air passing through aerosolization mechanism 16.Such distribution of the chase air in the capture chamber isaccomplished in part by providing check valve 92 which provides apressure drop so that the air within plenum 94 will be at asubstantially constant pressure. Proper air distribution is alsoprovided by curved flange member 66 which divides the air flow withinair channels 62 into an axial and a radial component. Hence, as thepatient inhales from the mouthpiece of the capture chamber, the chaseair flowing through aerosolization mechanism 16 is distributed into thecapture chamber in a manner such that the amount of air that mixes withthe powdered medicament is minimized.

Such a feature is illustrated in FIGS. 9 and 9A which illustrate how thepowdered medicament remains in a bolus that is evenly removed from thecapture chamber. In FIG. 9, the arrows illustrate the flow path of theincoming chase air as it moves through the capture chamber. As shown,the flow paths are generally parallel, indicating that substantiallynone of the chase air mixes with the aerosolized medicament. FIG. 9Aillustrates the mass fraction of air within a capture chamber atapproximately 100 milliseconds after inhalation is initiated. ContoursC1-C10 illustrate contours of mass fraction of air. Contour C1illustrates the powdered medicament bolus, and contour C10 illustratesthe incoming chase air. As shown, almost no mixing of the incoming chaseair occurs with the bolus. As a result, the bolus is lifted evenlyupward and out of the mouthpiece where it will be followed by the chaseair. In this manner, in the first part of the tidal volume, the patientreceives the powdered medicament. During the remainder of the tidalvolume, the chase air flows into the patient's lungs to assist indelivering the powdered medicament into the deep regions of the lungs.Hence, the front end of the inhalation cycle is employed to extract thepowdered medicament from the chamber while the remainder of theinhalation cycle serves to further deliver the powdered medicament tothe lungs.

As illustrated in FIG. 1, aerosolization mechanism 16 is offset from acenter of base unit 12. To produce the proper air flow into theaerosolization chamber, the location of ribs 64 (see FIG. 3) may bevaried to allow more chase air to pass through the quadrant facing thelarger area of the capture chamber so that the air flow may be moreevenly distributed within the capture chamber.

Referring now to FIG. 10, a cross-sectional side view of apparatus 10 ofFIG. 1 taken along lines 10-10 is shown. In the view of FIG. 10,aerosolization mechanism 16 is disposed within base unit 12, andreceptacle 22 is inserted into carriage assembly 38. FIG. 10 is providedto serve as a reference to illustrate the various views of FIGS.10A-10P, which describe the method of operation of apparatus 10. Aspreviously mentioned, apparatus 10 includes a receptacle interlock thatprevents operation of fire button 42 if receptacle 22 is only partiallyinserted into carriage assembly 38. Such a feature is illustrated inFIGS. 10A-10E. For convenience of illustration, aerosolization mechanism16 is not shown in base unit 12.

In FIG. 10A, base unit 12 is in a home or ready state. In the readystate, a receptacle interlock 102 is in a rest position. When in therest position, a lifter 104 of carriage assembly 38 is able to pivotupwardly about a pivot pin 106. Fire button 42 is also pivotallyattached to base unit 12 by a pivot pin 108 which allows a set of gearteeth 110 on fire button 42 to move when fire button 42 is depressed. Inturn, a set of gear teeth 112 on lifter 104 are moved by gear teeth 110to lift lifter 104 vertically upward. Base unit 12 further includes asensor arm 114 which is biased by a spring 116 in a rest position. Asdescribed in greater detail hereinafter, when sensor arm 114 is in therest position, receptacle interlock 102 is also in the rest positionwhere fire button 42 may be operated to lift lifter 104. Conveniently,sensor arm 114 includes a roller 118 over which receptacle 22 passeswhen inserted into carriage assembly 38. Although shown with a roller,it will be appreciated that a stationary mechanism may also be disposedin place of roller 118. Conveniently, a guide 120 is provided tofacilitate introduction of receptacle 22 into carriage assembly 38.

As shown in FIG. 10B, receptacle 22 is partially inserted into carriageassembly 38. When only partially inserted, pocket 98 of receptacle 22contacts roller 118, causing spring 116 to compress and sensor arm 114to pivot downward as shown. In turn, sensor arm 114 pivots receptacleinterlock 102 about a pivot pin 122. As shown in FIG. 10C, receptacleinterlock 102 includes a latch 124 which moves over a boss 126 on lifter104. When latch 124 is disposed over boss 126, lifter 104 is unable topivot about pivot pin 106. In turn, fire button 42 is unable to bedepressed. Hence, if receptacle 22 is only partially inserted asillustrated in FIG. 10B, fire button 42 may not be operated to liftcarriage assembly 38, thereby preventing receptacle 22 from beingcoupled with aerosolization mechanism 16.

When receptacle 22 is fully inserted into carriage assembly 38, pocket98 is positioned beyond roller 118 and is disposed within a well 128 ofsensor arm 114. When pocket 98 is disposed within well 128, spring 116moves sensor arm 114 back to the rest position as illustrated in FIG.10D. In turn, receptacle interlock 102 pivots back to the rest position.As illustrated in FIG. 10E, when receptacle interlock 102 is rotatedback to the rest position, latch 124 is now clear of boss 126 on lifter104. In this way, lifter 104 is not restricted by receptacle interlock102. However, as described in greater detail hereinafter, fire button 42may still not be operated until a valve interlock is released.

In summary, sensor arm 114 and receptacle interlock 102 serve to preventoperation of fire button 42 if receptacle 22 is only partially inserted.If not inserted, or if fully inserted, receptacle interlock 102 is in arest position where it does not prevent movement of lifter 104 ofcarriage assembly 38. When a valve interlock, as described hereinafter,is released, fire button 42 may be depressed to move carriage assembly38 upward so that receptacle 22 may engage with aerosolization mechanism16. In this way, a compliance feature is provided to prevent operationof aerosolization apparatus 10 if receptacle 22 is not correctlyinserted. Moreover, by providing well 128 in sensor arm 114, analignment mechanism is provided to ensure that pocket 98 will beproperly aligned with aerosolization mechanism 16. In this way,receptacle 22 is properly coupled to aerosolization mechanism 16 eachtime apparatus 10 is operated to produce the aerosolized medicament.

Referring now to FIGS. 10F-10K, operation of a valve interlock 130 willbe described. In order to extract an aerosolization medicament withinreceptacle 22, a pressurized gas must be supplied to aerosolizationmechanism 16 (see FIG. 10). As described in greater detail hereinafter,the pressurized gas is provided by operating handle 40 to pressurize thegas within a cylinder. Before the gas can be pressurized in thecylinder, a valve 132 must be closed and locked to allow the pressure tobuild up within the cylinder. As shown in FIG. 10F, valve interlock 130is in a ready state. In the ready state, valve 132 is unlocked and valveinterlock 130 prevents operation of fire button 42. As described ingreater detail hereinafter, valve interlock 130 is not released to allowfire button 42 to be operated until handle 40 is extended to a fullyextended position. Upon reaching the fully extended position, valve 132is locked and valve interlock 130 is released so that, as handle 40 ismoved back to the home or retracted position, the precise amount ofpressurized gas is produced and may be released upon operation of firebutton 42.

As shown in FIG. 10G, receptacle 22 is fully inserted so that receptacleinterlock 102 (see FIG. 10A) is in the ready state and is not engagedwith lifter 104. Handle 40 is in the home or retracted position andvalve 132 is unlocked so that there is no pressurized gas within baseunit 12. As shown in FIG. 10F, valve interlock 130 includes a latch 134which is positioned over a boss 136 on lifter 104 when valve interlock130 is in the rest or ready state. In the rest state, an actuator arm138, which is pivotally attached to base unit 12 by a pivot pin 140, isin an unlocked position so that valve 132 is unlocked. Base unit 12further includes a valve set arm 142. As shown in FIGS. 10F and 10G,valve set arm 142 is in an open position where valve set arm 142 engagesvalve interlock 130 to position latch 134 over boss 136. As best shownin FIG. 10G, handle 40 includes a pump link 144 which is pivotallyattached to base unit 12 by a pivot pin 146. Pump link 144 includes anose 148 which is spaced apart from valve set arm 142 when in the openposition.

As handle 40 is extended from the home position toward an extendedposition, pump link 144 pivots about pivot pin 146 causing nose 148 toengage valve set arm 142, as illustrated in FIG. 10H. Base unit 12includes a chassis 150 having a boss 152. As nose 148 pushes on valveset arm 142, valve set arm 142 slides under boss 152 on chassis 150 tolock valve set arm 142 in place. In turn, actuator arm 138 is rotatedabout pivot pin 140 (see FIG. 10I) to move actuator arm 138 to a lockedposition. In this way, valve 132 (see FIG. 10I) is closed and locked sothat, as handle 40 is moved back toward base unit 12, a pressurized gasmay be produced.

As best illustrated in FIG. 10I, as handle 40 is moved to the fullyextended position, actuator arm 138 is moved over center to the lockedposition where valve 132 is closed and locked. In the fully extendedposition, valve set arm 142 rotates valve interlock 130 to clear latch134 from boss 136. At this point, both valve interlock 130 andreceptacle interlock 102 are disengaged so that fire button 42 may beoperated to operate carriage assembly 38 and to open valve 132 to allowthe pressurized gas to be delivered to aerosolization mechanism 16 asdescribed in greater detail hereinafter.

Referring now to FIG. 10J, construction of valve 132 will be describedin greater detail. In FIG. 10J, receptacle is fully inserted and handle40 has moved to the fully extended position so that both interlocks 130and 102 have been released. Valve 132 is constructed of a housing 154having a passage 156 which is aligned with port 88 (see FIG. 6) whenaerosolization mechanism is inserted into base unit 12. Disposed acrosspassage 156 is a valve seat 158. Extending from valve seat 158 is arolling diaphragm 160 which terminates in an O-ring 162. In FIG. 10J, avalve actuator 164 of actuator arm 138 (see FIG. 10I) is firmly pressedagainst valve seat 158. As such, valve 132 is in the closed, lockedposition. Housing 154 further includes a lumen 166 for receiving a highpressurized gas from a pressurization cylinder within base unit 12 asdescribed in greater detail hereinafter. Conveniently, a fitting 168 isprovided on housing 154 to allow a tube to be coupled to housing 154.

When valve 132 is in the closed and locked position, gasses areprevented from travelling from lumen 166 through passage 156. As such,when handle 40 is moved back to the home or retracted position, apressurized gas will be produced. When valve 132 is opened, the highpressurized gas will pass through passage 156 and into aerosolizationmechanism 16 to extract the powdered medicament from receptacle 22.

Referring back to FIG. 10D, valve actuator 164 is shown in an unlockedposition where handle 40 has not yet been fully extended. In theunlocked position, valve seat 158 still covers passage 156. In this way,when handle 40 is being extended, air is prevented from being drawnthrough passage 156 and lumen 166. Instead, the pressurization cylinderwhich pressurizes the air upon operation of handle 40 is filled with airthrough a check valve in a bottom of base unit 12 as described ingreater detail hereinafter. In this manner, any residual powderedmedicament which is disposed within aerosolization mechanism 16 will begenerally prevented from being drawn through valve 132 and into thepressurization cylinder where it may hinder operation of apparatus 10.Although in the closed state prior to full extension of handle 40, valveseat 158 does not provide a seal to allow pressurized gas to be producedwithin the cylinder until valve actuator 164 is in the locked position.In this manner, if handle 40 is only partially extended and then movedback to the home position, gasses from the cylinder will be free to movethrough lumen 166 and through valve 132.

Referring now to FIG. 10K, apparatus 10 is shown with aerosolizationmechanism 16 inserted into base, unit 12. Receptacle 22 is fullyinserted and handle 40 has been moved back to the home position afterbeing fully extended so that both interlocks 102 and 130 have beenreleased. With both interlocks clear, fire button 42 is ready to bepushed to begin the aerosolization process. As shown, when receptacle 22is fully inserted, pocket 98 is aligned with pointed tip 50 and sidepunches 80.

As illustrated in FIG. 10L, when fire button 42 is pushed, gear teeth110 are pivoted about pivot pin 108, causing lifter 104 of carriageassembly 38 to move receptacle 22 toward aerosolization mechanism 16.When fully depressed, pointed tip 50 and side punches 80 pierce throughreceptacle 22 and enter into pocket 98 as shown. Stop 86 engagescarriage assembly 38 (see FIG. 10N) to ensure that pointed tip 50 andside punches 80 are not pressed through the bottom of pocket 98 whileseal 87 provides a seal between aerosolization mechanism 16 andreceptacle 22. Depression of fire button 42 causes valve actuator 164 ofactuator arm 138 to be released from its over-center position, therebyunlocking valve 132. The high pressurized gas stored within base unit 12then flows through lumen 166 as shown by the arrow, causing valve 132 to“pop open.” More specifically, the release of valve actuator 164 causesthe high pressurized gas to come into contact with the underside ofdiaphragm 160 causing valve seat 158 to be lifted from passage 156. Inthis manner, air is allowed to flow through passage 156 and intoaerosolization mechanism 16. The high pressurized gas then extracts thepowdered medicament from pocket 98, deagglomerates the powderedmedicament and disperses the powdered medicament into the capturechamber as previously described.

One particular advantage of aerosolization apparatus 10 is that thepowdered medicament is extracted from receptacle 22 almost immediatelyafter it has been pierced by aerosolization mechanism 16. In thismanner, the powdered medicament within receptacle 22 remains fresh untilit is aerosolized.

Referring now to FIGS. 10M and 10N, operation of fire button 42 torelease actuator arm 138 from the locked position will be described.Fire button 42 includes a tab 170 which engages a post 172 on valve setarm 142. As fire button 42 is further depressed, tab 170 pushes valveset arm 142 out from under boss 152 on chassis 150 (see FIG. 10H). Inturn, valve actuator arm 138 is allowed to move back away from itsover-center position, unclamping diaphragm 160 (see FIG. 10L). Asillustrated in FIG. 10N, fire button 42 is fully depressed so that post172 on set arm 142 is in a released position.

Still referring to FIGS. 10M and 10N, as fire button 42 is pressed, gearteeth 110 and 112 operate to transfer trigger motion from fire button 42to lifter 104. A spring beam 174 is included on lifer 104 and engages anotch 176 in carriage assembly 38. Spring beam 174 is employed to raisecarriage assembly 38 so that receptacle 22 may be coupled toaerosolization mechanism 16. As illustrated in FIG. 10M, stop 86 onaerosolization mechanism 16 has not quite come into contact withcarriage assembly 38. In FIG. 10N, carriage assembly has engaged stop 86to stop motion of carriage assembly 38. Further, spring beam 174 isdeformed due to the further upward travel of lifter 104. In this way,spring beam 174 will serve to lower carriage assembly 38 back to thestarting position after inhalation is complete as described hereinafter.

Base unit 12 includes a hook 178 which is coupled to release button 46(see FIG. 10L). Hook 178 catches a tab 180 on lifter 104 when carriageassembly 38 is fully raised and the pressurized gas has been released asillustrated in FIG. 10O. When release button 46 is pressed, hook 178 isreleased from tab 180 so that carriage assembly 38 may be lowered to thestarting position. As previously described, spring beam 174 assists inmoving carriage assembly 38 back to the starting position. As shown inFIG. 10P, carriage assembly 38 has been returned to the starting orready position where receptacle 22 may be removed by pulling it fromcarriage assembly 38.

One particular advantage of employing release button 46 is thataerosolization mechanism 16 remains coupled to receptacle 22 until firebutton 42 is pressed. In this way, a user is prevented from piercing areceptacle and then lowering carriage assembly 38 without aerosolizingthe medicament.

Referring now to FIGS. 11-11B and 12-12B, operation of handle 40 toproduce a pressurized gas for delivery aerosolization mechanism 16 willbe described. Handle 40 is coupled to pump link 144 via a screw 182.Pump link 144 is further coupled by a pivot pin 184 to a cylinder 186. Apiston 188 is pivotally attached by a pivot pin 190 to chassis 150 ofbase unit 12. Piston 188 is slidable within cylinder 186 to produce apressurized gas. Cylinder 186 further includes an opening 192 to which atube (not shown) is connected. The tube extends through base unit 12 andis coupled to fitting 168 to hydraulically couple cylinder 186 withvalve 132 if valve 132 is not in the locked position, translation ofpiston 188 within cylinder 186 causes diaphragm 160 to flex, therebyallowing air to pass through valve 132 as previously described. If,however, valve 132 is locked, translation of piston 188 within cylinder186 produces a pressurized charge of gas within cylinder 186. In FIGS.11-11B, handle 40 has not quite reached the fully extended position. Assuch, valve actuator 164 is not yet in the locked position. In FIGS.12-12B, handle 40 has been extended to the fully extended position tolock valve actuator 164 of actuator arm 138 and then moved back to thehome position. As such, a pressurized gas exists within cylinder 186 andis ready for delivery to aerosolization mechanism 16 upon operation offire button 42 as previously described.

As best shown in FIG. 11A, use of pivot pins 184 and 190 allows cylinder186 to remain generally aligned with piston 188 during extension andretraction of handle 40. As such, the amount of wear between cylinder186 and piston 188 is greatly reduced. Further, maintaining properalignment between cylinder 186 and piston 188 reduces the amount offorce required to move handle 40 when pressurizing the gas. For example,when cylinder 186 has a volume of approximately 8 ml at the fullyextended position, a force of approximately ten pounds will be requiredto move handle 40 back to the home position and pressurize the gas.Maintaining piston 188 generally aligned with cylinder 186 duringoperation of handle also allows a generally constant or smooth force tobe employed when operating handle 40.

Still referring to FIG. 11A, piston 188 includes a check valve 194 andfilter 196. Check valve 194 is configured so that, as handle 40 isextended, air is allowed to enter into cylinder 186 through check valve194. When handle 40 is moved back to the home position, check valve 194closes so that the pressurized gas may be produced within cylinder 186.Filter 196 is provided to filter the air entering into cylinder 186.Errant powder from previous operations may fall into bottom of base unit12. Filter 196 prevents such powder from entering into cylinder 186. Tofurther assist in preventing errant powder from entering into cylinder186, cylinder 186 is mounted such that an open end 198 of cylinder 186is pointed generally downward. In this way, errant powder fallingthrough base unit 12 will not fall directly onto piston 188 where it maytend to be drawn into cylinder 186 during operation.

As previously described, if receptacle 22 is not fully inserted intocarriage assembly 38, fire button 42 may not be operated to couplereceptacle 22 to aerosolization mechanism 16. Hence, receptacles usedwith aerosolization apparatus 10 may be keyed to prevent completeinsertion of the receptacle into carriage assembly 38 unless the properreceptacle is being inserted. In this way, the receptacles may be keyedaccording to the powdered medicament they contain so that a patient willnot receive an improper medication. An exemplary scheme for keying thereceptacles is illustrated in FIGS. 13 and 14. In FIG. 13, a receptacle22′ includes a notch 200. Receptacle 22′ is used with an aerosolizationapparatus where the carriage assembly includes a key (such as key 400shown in FIGS. 12A and 12B, in one approach) which is received withinnotch 200 when receptacle 22′ is inserted into the carriage assembly. Ifthe receptacle does not include notch 200, the receptacle may not befully inserted, thereby preventing operation of the carriage assembly aspreviously described. As illustrated in FIG. 14, a receptacle 22″includes a pair of notches 202 and 204. With such a configuration, thecarriage assembly will include a pair of keys (which are not shown inthe figures) that are aligned with notches 202 and 204 to allowreceptacle 22″ to be fully inserted. By increasing the number andplacement of the various notches and keys, a wide variety ofcombinations may be produced so that receptacles with a wide assortmentof drugs may be keyed to particular aerosolization apparatus to preventincorrect delivery to a patient. Although shown with rectangularnotches, it will be appreciated that any geometry of notch orindentation may be employed as long as full insertion of the receptacleis prevented unless the receptacle is intended for a particularaerosolization apparatus.

The foregoing invention has now been described in detail by way ofillustration and example, for purposes of clarity of understanding.However, it will be appreciated that certain changes and modificationsmay be practiced within the scope of the dependent claims.

1. A system, comprising: a receptacle comprising at least one notch anda cavity that holds medicament; and a device comprising: a housing, thehousing having an opening that receives and supports the receptacle; anextraction tube that engages the receptacle; at least one piercingelement that cuts the receptacle to create at least one opening in awall of the receptacle; a first and a second interlock which areoperably engageable with a carriage assembly to prevent coupling of thereceptacle with the extraction tube; and at least one key that mateswith the at least one notch of the receptacle, wherein when thereceptacle is inserted into the opening that receives the receptacle andthe at least one key mates with the at least one notch of thereceptacle, the at least one piercing element is allowed to cut thereceptacle, wherein when the receptacle is partially inserted into theopening that receives the receptacle and the at least one key does notmate with the at least one notch of the receptacle, the at least onepiercing element is prevented from cutting the receptacle, wherein thefirst interlock is released to allow movement of the carriage uponmovement of a handle to an extended position, and wherein the secondinterlock is engaged when the receptacle is partially inserted into thecarriage assembly.
 2. The system of claim 1, wherein the at least onenotch of the receptacle comprises two notches.
 3. The system of claim 1,wherein the at least one piercing element comprises a plurality ofpiercing elements that cut a plurality of holes in the receptacle. 4.The system of claim 1, wherein when the receptacle is inserted into theopening that receives the receptacle and the at least one key mates withthe at least one notch of the receptacle, the cavity of the receptacleis aligned with the at least one piercing element.
 5. The system ofclaim 1, wherein when the receptacle is inserted into the opening thatreceives the receptacle and the at least one key mates with the at leastone notch of the receptacle, the extraction tube is allowed to engagethe receptacle.
 6. The system of claim 1, wherein when the receptacle ispartially inserted into the opening that receives the receptacle and theat least one key does not mate with the at least one notch, theextraction tube is prevented from engaging the receptacle.
 7. The systemof claim 1, wherein when the receptacle is inserted into the openingthat receives the receptacle and the at least one key mates with the atleast one notch of the receptacle, a portion of the receptacle remainsoutside the device.
 8. The system of claim 1, wherein the device furthercomprises a well that receives the receptacle.
 9. The system of claim 1,wherein the device further comprises a deagglomeration channel incommunication with the extraction tube.
 10. The system of claim 1,wherein the device further comprises a check valve that opens when apatient inhales at a threshold pressure.
 11. The system of claim 1,wherein the at least one opening is an air inlet opening.
 12. The systemof claim 1, wherein the receptacle comprises a powder-containingreceptacle, wherein the extraction tube is structured and arranged todeliver the powder from the receptacle to an outlet, and wherein thepiercing element is configured to create at least one opening in thewall of the receptacle by causing a puncture in the wall and causing atearing of the wall.
 13. The system of claim 1, wherein the devicefurther comprises a carriage assembly adapted to receive the receptacleand to couple the receptacle to the extraction tube.
 14. The system ofclaim 13, wherein the device further comprises a fire button that isconnected to the carriage assembly to move the carriage assembly towardthe extraction tube.
 15. The system of claim 1, wherein the devicefurther comprises a capture chamber.
 16. The system of claim 1, whereinthe at least one notch of the receptacle comprises two notches, andwherein the at least one piercing element comprises a plurality ofpiercing elements that cut a plurality of holes in the receptacle. 17.The system of claim 1, wherein when the receptacle is inserted into theopening that receives the receptacle and the at least one key mates withthe at least one notch of the receptacle, the cavity of the receptacleis aligned with the at least one piercing element, and wherein the atleast one piercing element comprises a plurality of piercing elementsthat cut a plurality of holes in the receptacle.
 18. The system of claim1, wherein the device further comprises a deagglomeration channel incommunication with the extraction tube, and wherein the at least onepiercing element comprises a plurality of piercing elements that cut aplurality of holes in the receptacle.
 19. The system of claim 1, whereinthe device further comprises a check valve that opens when a patientinhales at a threshold pressure, and wherein the at least one piercingelement comprises a plurality of piercing elements that cut a pluralityof holes in the receptacle.